WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

This study has been completed.

Sponsor:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT00129545

First Posted: August 12, 2005

Last Update Posted: May 15, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events [ Time Frame: 5 years ]

Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.

Secondary Outcome Measures:

Procedure Success [ Time Frame: Initial implant procedure ]

Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin

Drug: Warfarin

Subjects receive warfarin

Other Name: Coumadin

Roll-in

Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.

Device: WATCHMAN Left Atrial Appendage Closure Technology

Implant of WATCHMAN Left Atrial Appendage Closure Technology

Other Name: WATCHMAN

Detailed Description:

The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Eligibility

Information from the National Library of Medicine

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